Progress 09/01/09 to 08/31/12
Outputs
Target Audience: Veterinarians and producers interested in minimizing the impact of disease and ensuring a high-quality, abundant, affordable, wholesome, and safe food supply. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided? As mentioned above, Dr. Darin Madson (ISU Diagnostic Pathologist, who recently completed his Veterinary Pathology training and received ACVP board certification in 2011) attended the FAD diagnostician training course in November 2011. Additionally, Dr. Phil Gauger (ISU VDL Diagnostic Pathologist and Section Leader of ISU VDL’s Molecular and Virology Diagnostic Services) has been working very closely with the molecular technical staff facilitate our staff’s understanding of the technical aspects of the assays being conducted, pathogens being tested, and the impact of their role in safeguarding US animal agriculture. How have the results been disseminated to communities of interest? All of the USDA associated surveillance test results conducted at the ISU VDL are reported to the NAHLN. What do you plan to do during the next reporting period to accomplish the goals? Moving forward into 2012-2013, we propose to build upon a number the current project’s accomplishments to further the ISU VDL’s contribution to the NAHLN. The proposed objectives are aimed at: 1) continual improvement of quality system, 2) enhancing ISU VDL staff training on foreign and emerging animal diseases, 3) advancing ISU LIMS capabilities and connectivity, and 4) enhancing FAD preparedness and NAHLN testing capacities. 1. Quality System: The ISU VDL is committed to continually improving the effectiveness of its quality program. Our primary objective is to establish an improved system for the real-time monitoring of the non-conformances/corrective and preventative actions occurring across the laboratory by linking the data being logged and stored in Q-Pulse® to a user-friendly and readily accessible report. This effort is aimed at distilling a tremendous amount of information into a very functional and easy to understand reporting tool that the management of the laboratory can utilize to better quantify, understand, and monitor the progress of these critical events being logged and managed throughout the laboratory. Developing a real-time and meaningful CA/PA module reporting tool will enhance the visibility of this information, section-based accountability throughout the laboratory, and the ISU VDL management team’s ability to use this information to improve the performance of the laboratory. Additionally, our goal is to continue our efforts to more fully harness the capabilities of Q-pulse®. Specifically, we are planning to more fully capture the benefits of utilizing the Q-pulse® equipment module across all sections of the laboratory. 2. Staff Training in Foreign and Emerging Animal Diseases: Enhancing ISU VDL technical staff training on foreign and emerging animal disease is an ongoing need and is essential for sustaining preparedness. The ISU VDL is planning to have Dr. Eric Burrough (hired full-time as a board-certified pathologist in FY 2012) participate in the FAD-training course December 2012 at Plum Island. Similarly, we continue to feel it important that the VDL technical staff understand the pathogens and implications of the foreign and emerging disease diagnostic work they conduct. The ISU VDL molecular diagnostic section is the largest and fastest growing section within the laboratory and will have at least 6 technical staff being proficiency-tested in the coming project year that are all newcomers to the ISU VDL. ISU VDL diagnosticians are planning to conduct a series of brief continuing educational sessions for technical staff actively involved in NAHLN surveillance testing and reporting. 3. Laboratory Information Management System (LIMS): Continuing to enhance ISU LIMS capabilities and connectivity is an ongoing and strategic initiative of the ISU VDL. At the present time, ISU LIMS cannot receive messages from external laboratories and our ability to interface with the broad array of high-throughput diagnostic instrumentation is challenging. Therefore, our objective is to purchase, install, and begin to utilize Rhapsody® integration software along with a server to support this tool. On-boarding this technology will allow the ISU VDL to receive HL-7 order messages, improves our ability to interface high-throughput diagnostic instrumentation with ISU LIMS, and streamlines automated reporting to external databases. The ISU VDL remains committed toward continuing to improve ISU LIMS connectivity with VDL client diagnostic databases and enhancing ISU LIMS role in supporting the number of PRRSV area regional control (ARC) projects that have started-up in numerous locations over the past 12 to 24 months. A primary objective is to establish the ability of ISU LIMS to message PRRSV diagnostic results directly to an epidemiologic database tool (i.e., Disease BioPortal®, developed at the University of California Davis Center for Animal Disease Modeling and Surveillance). Disease BioPortal® is a broadly capable database with a multitude of regional health-status monitoring, sequencing analysis, and time-based mapping tools. Disease BioPortal® is being used to support a number of PRRSV ARC projects. However, the submission specific identifiers and PRRSV diagnostic results being used to populate Disease BioPortal® are currently being manually entered due to a lack of connectivity with ISU LIMS. This lack of connectivity seems to challenge the scalability and real-time functionality of this otherwise powerful regional health-status monitoring tool. Thus, we are planning to proceed with the development work required to establish the ability to message PRRSV results (via HL-7 messaging) to Disease BioPortal®. It would be our hope that this investment of time and resources establishes a model of delivering diagnostic results to Disease BioPortal® that could be subsequently used by other NAHLN veterinary diagnostic laboratories. ISU VDL clientele largely view and/or receive diagnostic information electronically. Submission forms are currently scanned and stored in Westbrook Fortis SE®, and linked to the case record in ISU LIMS. Unfortunately, these scanned documents cannot be viewed by ISU VDL web clients without access to the Fortis software. Thus, the ISU VDL has just recently purchased the Simple Index Scanning Software®. Our objective in the coming year is to fully integrate Simple Index Scanning Software® to enable ISU VDL submitters to view scanned files in LIMS as a pdf file. This will allow submitting veterinarians web-based access to all of the notes and information included on the submission forms as a viewable component of the case record. 4. FAD preparedness and NAHLN testing capacities: Continuing to sustain an adequate number of proficiency tested staff is essential to ensuring the laboratory can assume surge-capacity testing responsibilities and/or provide qualified technical staff to other NAHLN labs during a crisis. Our goal continues to be to sustain 8 molecular and 4 serology staff proficient in performing the primary NAHLN assays conducted at the ISU VDL. ISU VDL’s molecular diagnostic services have continued to grow at a rapid pace (>150,000 PCR assays performed in the current year). Unfortunately, our access to additional laboratory space has not grown with this increased demand for high-quality PCR diagnostics and continuing expectations for same-day turn-around time for most of the high-volume PCR and serologic assays conducted. Thus, we are planning to re-purpose a freezer-room (adjacent to the molecular section) into a laboratory space that will increase our laboratories capabilities to efficiently receive and process incoming submissions that are commonly being spun, poured into snap-cap tubes, and split for same-day molecular and serologic testing. We are proposing to purchase 2 additional laminar-flow hoods (one for each of the sample receiving/processing stations being installed) for this renovation. Repurposing and outfitting this space with the appropriate equipment is a strategic investment to increase the ISU VDL’s molecular and serologic testing surge capacity. The ISU VDL is planning to continue its open invitation, preparedness, and engagement with Iowa’s state and federal animal health officials by participating in (Iowa-based) FAD investigations. ISU VDL’s role will be to receive duplicate samples into the ISU VDL BSL-3 diagnostic facility, conduct testing, and communicate results appropriately. This effort is intended to only complement existing protocols and only occur during FAD investigations where duplicate samples are readily accessible. Participating in these investigations (when possible) with the Iowa-based federal and state animal health officials is the essential component to sustaining and enhancing our preparedness.
Impacts
What was accomplished under these goals?
1. Quality System: The ISU VDL continues to make ongoing improvements to its quality program. Improvements continue to be driven by the ISU VDL Quality System Management Team that included ~50% of three highly-capable technical staff (Kelly Boesenberg-Smith, Jessica Boor, and Wayne Chittick) and one faculty member (Dr. John Johnson). They continued to drive improvements to ISU VDL’s quality system, quality manual, laboratory policies and diagnostic services. This team coordinates a quantitative (section-led) self-auditing process, the annual management review, and conducts the annual third-party internal auditing procedures. Significant improvements were made in utilizing Q-pulse across all sections of the laboratory. The ISU VDL established a more-clear and transparent system of monitoring employee training and proficiency testing. Developing and implementing this improved reporting tool has greatly enhanced the laboratory’s ability to more effectively define, manage, and monitor staff training and proficiency testing across the 12-sections and > 115 employees in the laboratory. These accomplishments have encouraged a similar improvement effort in the upcoming year to develop and implement a more user-friendly and real-time CAPA module reporting tool. 2. Staff training in foreign and emerging animal disease diagnostics: Foreign and emerging animal disease training is a critical and ongoing need for sustaining the laboratory’s preparedness. Dr. Darin Madson (ISU Diagnostic Pathologist, who recently completed his Veterinary Pathology training and received ACVP board certification in 2011) attended the FAD diagnostician training course in November 2011. This course continues to be an extremely effective means of delivering FAD training directly into the hands and minds of ISU VDL’s Diagnostic Pathologists who are the front-lines of coordinating the approximately 45,000 diagnostic case submissions ( > 95% food-animal) being submitted to the ISU VDL each year. This FAD diagnostician training school is highly regarded and serves as the only first-hand or hands-on exposure our diagnosticians have to these diseases of high consequence (i.e., foot and mouth disease, classical swine fever, vesicular stomatitis, etc.). It is also important that the technical staff conducting the FAD and emerging disease surveillance testing have a basic understanding of these diseases and recognize the importance of their role in the overall national surveillance effort. Dr. Phil Gauger (ISU VDL Diagnostic Pathologist, and was most recently named Section Leader of ISU VDL’s Molecular and Virology Diagnostic Services) has been working very closely with the molecular technical staff throughout the past year. We have capitalized on the close working relationship between our veterinary diagnosticians and technical staff to facilitate our staff’s understanding of the technical aspects of the assays being conducted, pathogens being tested, and the impact of their role in safeguarding US animal agriculture. 3. Laboratory Information Management System (LIMS): The ISU VDL remains committed to expanding the use of electronic submissions and reporting. Enhancing ISU LIMS capabilities and connectivity within the laboratory, between laboratories, and with our clients’ increasingly sophisticated diagnostic information databases is of utmost importance for the ISU VDL’s future vitality and ability to effectively serve during a national animal health crisis. Establishing robust systems to readily receive, process, and distribute diagnostic information electronically improves case histories; enhances the ability to capture animal and site-specific demographic information; requires fewer clerical resources; reduces transcription errors; improves the quality of the diagnostic investigations completed; enhances the ability to conduct meaningful retrospective epidemiology inquiries; and significantly increases the overall efficiency and capacity of the laboratory. Unfortunately, advancing ISU LIMS capabilities was the primary focus area eliminated from the 2011-2012 project due to the 39% reduction in funding (-$116,000) experienced after the initial application for the award. Thus, there were only modest investments and improvements to ISU LIMS. The ISU VDL did move forward (independent of NAHLN funding) to recently purchase the Simple Index Scanner Software®. Once on-boarded, this investment will enable submitting veterinarians to view their case submission forms as a component of the permanent case record on ISU LIM’s web-reporting platform. We are proposing to allocate significantly more of the 2012-2013 NAHLN project resources toward advancing ISU LIMS capabilities and fully implementing the recently acquired Simple Index Scanning Software®. 4. Enhancing FAD preparedness and NAHLN testing capacities: The ISU VDL continued to expand technical staff training and proficiency in foreign and emerging animal disease diagnostics. Maintaining adequate depth in proficiency-tested staff is essential for the ISU VDL’s ability to provide surge capacity to the NAHLN during a time of crisis. The ISU VDL molecular section is a large, fast-paced, and rapidly growing unit that is on-pace to conduct >135,000 PCR assays during the current project. The ISU VDL’s proven capabilities and capacity to manage high-throughput molecular testing demands for non-foreign animal disease diagnostics positions our laboratory well to support NAHLN surge capacity needs. Current preparedness for the tests performed at the ISU VDL includes: Classical Swine Fever: 11 employees proficiency tested Avian Influenza: 11 employees proficiency tested Exotic Newcastle Disease: 11 employees proficiency tested Foot and Mouth Disease: 7 employees proficiency tested Influenza A (SIV): 7 employees proficiency tested Pseudorabies: 4 employees proficiency tested The following tests were performed at the ISU VDL under various USDA-APHIS surveillance programs from July 1, 2011 – May 17th 2012 Avian Influenza 176 Classical Swine Fever 1,110 Influenza A (SIV) 1,114 Influenza A Virus Isolation (SIV) 397 Influenza A Fully Sequenced (SIV) 171 Pseudorabies 6,354 FMD 0 A primary objective of the current project was to increase the resources allocated to the Influenza A (SIV) surveillance initiative to improve the turn-around time associated with conducting the extensive sequencing analysis and depositing sequencing information into GenBank. The ISU VDL has screened 2,250 influenza-like illness specimens of swine, conducted 757 virus isolation attempts, and fully-sequenced 334 Influenza A viral isolates from swine since the inception of the National Surveillance Plan for Swine Influenza Virus in Pigs. We have made substantial progress over the past year working through the significant back-log of Influenza sequencing cases and are now completely current. This significant improvement was accomplished by hiring and training an extremely capable full-time staff member that is almost exclusively committed to conducting Influenza A sequencing, sequencing analysis, and depositing all of the sequencing information into GenBank. This has been an exemplary effort over the past number of months. The ISU VDL is now adequately staffed and fully capable of delivering this Influenza A sequencing information in a timely manner. An unexpected preparedness activity accomplished in 2011-2012 involved conducting an extensive series of ventilation trouble-shooting investigations that eventually led us to replace some of the ISU VDL’s BSL-3 capable diagnostic facility’s ventilation equipment. Sustaining the functionality of this BSL-3 capable diagnostic facility is an essential and often costly element associated with maintaining our laboratory’s preparedness.
Publications
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Progress 09/01/10 to 08/31/11
Outputs
OUTPUTS: The Iowa State University Veterinary Diagnostic Laboratory (ISU VDL) continued to sustain adequate depth in technical staff who are proficiency-tested, prepared and active in foreign and emerging animal disease surveillance. Proficiency-tested technicians included: 8 for Foot and Mouth Disease, 7 for Classical Swine Fever, 7 for Swine Influenza, 5 for Avian Influenza, 4 for Pseudorabies, and 2 for Exotic Newcastle Disease. Under the various APHIS surveillance programs from July 1, 2010 to June 30, 2011, the ISU-VDL performed 10,919 tests for Pseudorabies, 2,971 tests for Avian Influenza, 1,249 tests for Classical Swine Fever, and 1,122 tests for Swine Influenza. In addition, the VDL conducted a steady-pace of high-throughput testing scenarios performing more than 125,000 molecular diagnostic assays for non-FAD agents. The ISU VDL participated in two multi-state FMD exercises with Kansas and South Dakota; and integrated Iowa's state and federal animal health officials into its FAD response/BSL-3 activation procedures by hosting a hands-on exercise of ISU VDL's BSL-3 facilities and practices associated with receiving, processing, testing, and reporting suspected FAD submissions. Significant investments were made to address maintenance needs of the ISU VDL's BSL-3 capable diagnostic facility by installing plastic paneling to the inside walls of the necropsy area and molecular diagnostic laboratory. The ISU VDL traded in a real-time PCR machine that operates on an alternative platform and replaced it with an AB7500Fast to enhance BSL-3 testing capacity. The ISU VDL Director of Operations presented proceeding papers at the Iowa State Swine Disease Conference and North American Veterinary Conference entitled "Veterinary Diagnostic Labs Role in Surveillance". The ISU VDL quality management team continued to coordinate a quantitative system of self-auditing, annual management review process, and conducted annual auditing procedures. Significant efforts have been made to expand the ISU VDL technical staff exposure, training, and utilization of the quality management system software (Q-Pulse). The ISU VDL Quality Management Team was recognized as the ISU CVM Team of the Year, which speaks well to their contributions. Improvements continue to be made expanding the ISU VDL's Laboratory Information Management System (ISU LIMS) capabilities, outreach, and connectivity. The ISU VDL hosted two best practice submission workshops during the Iowa Veterinary Medical Association Conference and piloted a key account management approach towards high-volume ISU VDL users on the use and benefits of web-submissions. Web submissions increased more than 25 percent, and electronic reporting continues to be the norm. The ISU VDL has been reaching out to enhance connectivity to a veterinary practice based LIMS, and has become engaged in an Iowa-based regional PRRSV project to better understand ISU LIMS role and capabilities in supporting regional animal health initiatives. The ISU VDL continued to play a leadership role in supporting the NAHLN in its efforts to improve electronic messaging capabilities and communication between laboratories. PARTICIPANTS: The ISU VDL faculty and staff. TARGET AUDIENCES: Veterinarians and producers interested in minimizing the impact of disease and ensuring a high-quality and safe food supply. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
The financial resources provided to the Iowa State University Veterinary Diagnostic Laboratory (ISU VDL) as a core laboratory in the National Animal Health Laboratory Network (NAHLN) are essential in enhancing animal disease monitoring capabilities and capacity, demonstrating competence and compliance of well-defined testing standards, supporting the development and implementation of quality assurance programs that drive the continuous improvement of the laboratory, increasing collaboration and connectivity between state and federal animal health officials and diagnostic laboratories, and improving foreign or emerging animal disease testing, surveillance, and containment capabilities. NAHLN's support of the ISU VDL is essential in driving the continual improvement of the laboratory's ability to adequately serve and protect the health and well-being of US food-animal agriculture and the safety and abundance of our nation's food-supply. Federal support through the NAHLN is a cornerstone of enhancing our laboratory, regional, and national preparedness to effectively monitor and respond to emerging diseases of importance to both animal and human health. These funds have enabled the ISU VDL the ability to maintain a BSL-3 capable diagnostic laboratory space and proficiency-trained diagnostic technicians that must be prepared when a disease outbreak occurs and utilized on a regular basis for foreign, emerging, and domestic disease surveillance. These funds also support laboratory information technology infrastructure, capabilities, and personnel to develop and use data systems necessary for secure management and transmission of sensitive laboratory data. Similarly, support through the NAHLN has been critical towards enhancing the ISU VDL's quality assurance programs that validate the accuracy and reliability of the test results to reassure decision-makers and foreign trading partners that they can have confidence in the results. In short, funding received through the NAHLN is used as an extremely efficient and effective means of leveraging the capabilities existing at the ISU VDL to enhance the US diagnostic system serving to protect animal health, human health, and the greater than100 billion dollar US animal agricultural economy.
Publications
- No publications reported this period
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Progress 09/01/09 to 08/31/10
Outputs
OUTPUTS: Significant progress has been made to improve and stream-line quality system at the Iowa State University Veterinary Diagnostic Laboratory (ISU VDL) during the 2009-2010 project. A quality management system software package (Q-Pulse) was purchased, installed, and brought on-line. The document control module within Q-Pulse was fully implemented. Human-resources committed to the Quality System Management Team were increased to include approximately fifty-percent of three highly-capable technical staff and one faculty member. An extensive review and updating of the ISU VDL quality manual was completed and a quantitative system of (section-led) self-auditing was established. ISU VDL's high-throughput molecular diagnostic capabilities increased both in number agents capable of being detected and in overall testing volume, completing more than 90,000 tests this past year. The ISU VDL expanded the scope of the NAHLN surveillance functions to include proficiency-trained staff and testing capabilities in CSF, FMD, END, AI, SIV molecular diagnostics and PRV serology. Most recently, the ISU VDL participated in a training exercise at Plum Island and subsequently have initiated proficiency-testing on the NAHLN African Swine Fever and Rinderpest PCR diagnostic assays. Significant advancements continue to be made to expand ISU VDL's LIMS capabilities, outreach, and connectivity. The ISU VDL can now receive both serology/molecular and tissue/necropsy submissions via the web. Advanced programming efforts have been made to enable specific disease diagnostic results within ISU LIMS to be readily mapped based on herd location information provided. This time-sensitive mapping tool can show the geographical progression of a specific diagnosis over time. The ISU VDL has supported efforts to expand outreach and connectivity of ISU LIMS to a peer diagnostic laboratory and a progressive veterinary practice-based LIMS system. ISU VDL continues to play a leadership role in supporting the NAHLN group in its efforts to expand and improve electronic messaging capabilities and communication between laboratories. The ISU VDL completed the documentation and training, and received the official BSL-3 diagnostic capable certification. Since receiving certification, efforts have been focused on ensuring the BSL-3 facility is fully-equipped and functional to perform BSL-3 level diagnostic procedures. ISU VDL technical staff have received training and initiated drilling BSL-3 activation exercises. The ISU VDL collaborated with NAHLN, Veterinary Services, National Surveillance Unit, Kansas State University-VDL, and National Pork Board, along with state and federal animal health officials from Iowa and Kansas in a pilot, two-state FMD table-top exercise. The ISU VDL also had a significant increase in the number of collaborations, meetings, and conference calls with state and federal animal and public health officials, federal animal and public-health agencies, and animal industry groups dealing with the circulation of 2009 pH1N1 influenza virus and an increasing national interest in establishing a more comprehensive influenza surveillance program in US swine. PARTICIPANTS: The Iowa State University Veterinary Diagnostic Laboratory (ISU VDL) faculty and staff. TARGET AUDIENCES: Veterinarians, food-animal producers, along with the state and federal officials and agencies charged with protecting animal health, human health, and preserving a safe and abundant food supply. PROJECT MODIFICATIONS: Not relevant to this project.
Impacts
The funding received and ongoing support for the continued membership of the Iowa State University Veterinary Diagnostic Laboratory (ISU VDL) as a core laboratory in the National Animal Health Laboratory Network (NAHLN) plays an essential role in enhancing the continual improvement of the ISU-VDL's diagnostic capabilities, capacity, connectivity, outreach, and overall preparedness. The 2009-2010 project objectives were aimed at increasing the effectiveness of and streamlining the quality system, enhancing molecular testing capabilities and training, expanding the use and capabilities of the Laboratory Information Management System (LIMS), improving the utilization and functionality of our BSL-3-capable diagnostic facility, and increasing collaboration with health officials. Each of these objectives and project deliverables (described in the project outputs) have contributed towards a sustainable improvement in the ISU VDL's capabilities, preparedness, and overall contribution to advancing the NAHLN's mission. Enhancing animal disease monitoring capabilities and capacity, demonstrating competence and compliance of well-defined testing standards, increasing collaboration and connectivity between state and federal diagnostic laboratories, and improving foreign or emerging animal disease testing and containment capabilities are all core objectives of the ISU VDL and the NAHLN. The ISU VDL is well-suited and appreciative for the opportunity to play an ongoing role aiding in the continual improvement, effectiveness, and sustainability of the NAHLN.
Publications
- No publications reported this period
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